AM-101 TACTT1 Results Released

[Erlend]

Where are those numbers?

At Day 90, average reductions from baseline levels exceeded 50 per cent for subjective loudness, annoyance and sleep difficulties and close to 50 per cent for the TBF-12 score. Effects were somewhat less pronounced in patients with bilateral rather than unilateral tinnitus since only one ear was treated in the study as a precautionary safety measure.

http://pharmabiz.com/NewsDetails.aspx?aid=69792&sid=2

 

[cullenbohannon]

Where are those numbers?

First ent I found that was actually

Check out the link Hudson posted on the first page and this one below. Also there is a study I posted on the previous page they did on rats that were effective. I believe there are links in through out the thread.

http://www.aurismedical.com/p/news/news_34.php?lg=en

This thread may have info as well. https://www.tinnitustalk.com/threads/am-101.366/page-5#post-38369

 

[Mpt]

what do you think 90 day improvement for the placebo group was...? - since most people do see some improvement in subjective discomfort over the first few months, even if its only 20% that means am101 is responsible for 30% improvement really... i find it a little depressing that several people doing the study -- the member of this site fish and rusty shakleford from reddit have doubts as to whether the drug was responsible for their improvement or whether it was habituation-- im having doubts-- someone convince me otherwise... i need some hope

 

[cullenbohannon]

Patients suffering from acute tinnitus with established cochlear origin (i.e. after noise trauma or otitis media) who received AM-101 at 0.81 mg/ml showed a statistically significant improvement (p <0.05 or <0.01) in tinnitus loudness, annoyance as well as tinnitus-related sleep difficulties and activity and participation limitations (TBF-12 questionnaire). In most cases the treatment effect started to appear within a few days from administration and continued to increase over the follow-up period.


http://www.aurismedical.com/p/news/news_34.php?lg=en

This means that people who received the placebo over that same period who did not know they were receiving the placebo did not have the same results as the the group actually administered the drug. at .81mg
@Mpt so it still is more effective than doing nothing.

 

[JohnG]

I already have a reduction in my T in two months and I didn't get any treatment whatsoever. I think this is a tricky fish to measure. T is so subjective from the patient's point of view.

 

[Mpt]

I have spoken to one guy who had the treatment who said his tinnitus got quiet for a period of several days after the treatment but then flared back up-- why would ketamine permanently reduce glutamate action when it leaves the body eventually-- sorry im just naturally skeptical

 

[cullenbohannon]

I'm no scientist so I can't answer that but I do believe they talk about it on the website. It also gives information on the original study which inspired the idea so you can look into that but I know my doctor told me he had a patient who had very good results. I don't think anyones gonna be able to convince you otherwise but I would suggest researching the studies the reaction that occurs if that will give you peace of mind.

I have spoken to one guy who had the treatment who said his tinnitus got quiet for a period of several days after the treatment but then flared back up-- why would ketamine permanently reduce glutamate action when it leaves the body eventually-- sorry im just naturally skeptical

 

[urtica]

in the manual i have they say it cause a non reversible significant improvement! the dose i got (or the placebo) btw. is 0,25ml gel with 0,87mg/ml Esketamine. quite a small dose! btw. my t is really low today! even with alcohol now my left untreated ear has a louder t than the treated right ear!

 

[JohnG]

Hey Urtica. That is great. You have one treated ear and the other (possible treatment). So this may be pretty obvious then. I was also thinking of just doing my worst ear.

 

[JohnG]

Sorry, I meant to say you have a possible treated ear and definitely one not treated. So it seems pretty obvious if the other is doing way better that you are the lucky 50% treated group!

 

[yonkapin]

in the manual i have they say it cause a non reversible significant improvement! the dose i got (or the placebo) btw. is 0,25ml gel with 0,87mg/ml Esketamine. quite a small dose! btw. my t is really low today! even with alcohol now my left untreated ear has a louder t than the treated right ear!

Wanted to just quickly chime in and say thanks for letting us know how you are going, really appreciate it!

 

[super07]

in the manual i have they say it cause a non reversible significant improvement! the dose i got (or the placebo) btw. is 0,25ml gel with 0,87mg/ml Esketamine. quite a small dose! btw. my t is really low today! even with alcohol now my left untreated ear has a louder t than the treated right ear!

Awesome news, urtica! I'm so glad your T has come back down. Thanks for keeping us in the loop!

 

[urtica]

my only worry right now is that my (treted) ear is still aching, when I'm for example yawning or mowing my inner ear. Also when I was in bed the last day, i could hear my pulse on my eardrum! I've never had that before. I'm calling my study-doctor today to ask her. On the other hand: I could hear my pulse and not my T !!

 

[attheedgeofscience]

Yes, i know I am overpositive about AM101, but




Looks like your hearing is significantly better than before. Problem is, you may have notches between some frequencies. For example, my audiogram looks good (de jure i have healthy hearing), but i can feel, than my hearing is harmed. I have relatively huge notch at 4200 Hz, some betweet 5-7Khz and huge notch between 12-13 Khz on right ear. Left ear is better, but there are too some notches. Try http://www.onlinetonegenerator.com/hearingtest.html - you need Firefox browser to open it. Set volume to lowest as possible, because default volume of this site is high and hear. It goes from 0-20Khz. Of course, it can't show Db loses, but can show, if you have some weak places in your treshold range.

Notches are always a possibility, but since my "huge" 20 db notch at 2 kHz, left ear, is now gone, I have no reason to believe that hidden notches should then remain. On a less scientific note, I can mention that in everyday situations, my hearing is now so good that I can clearly hear conversations with my 33db earplugs in. And when I use headphones for eg. viewing CNN news or youtube videos on my computer, I have had to turn down the volume over the past year from 5% to 1% (and I have always been careful with my hearing, otherwise). My L40%/R50% tinnitus improvement from the stem cell treatments means that in everyday situations I can 1) fall asleep easily and without medication, 2) remain asleep, 3) my tinnitus is still audible in a quiet room, but it is no longer intrusive, and 4) my improvement is stable (ie. I don't get spikes or have "bad days").

As for your comment "Yes, i know I am overpositive about AM101", I have the following to say (and which is what I have also said before): there is only one way to find out - and that is to test it! And so, I will once again become a human guinea pig - or lab rat, if you prefer - and test the stuff. You can be sure that I will be discussing dosages and treatment method with the ENT specialist performing the procedure. I would not normally have joined an Internet forum (this is the first one I ever joined), but since I have certain "skills" in testing medical treatments and drugs before they become commercially available, I have decided to come forward and share what knowledge I can. What I do is not easy: it takes a lot of determination, connections, travel, research, and money for someone with a non-medical background. But, my instinct and gut-feeling tells me that I am on the right path. We shall see. And with that, there is also a lesson to be learnt by some/all of us here: with the will to succeed, it is possible to get results even with such difficult and otherwise incurable conditions as tinnitus. So try to stay positive for a while to come - and wait for my next "experiment" to finish. As with my stem cell treatments, I don't really know what to expect with the ketamine procedure, but remember:

"Adventure is worthwhile in itself"
--Amelia Earhart, Female Aviator

I will be taking a break from TT once again and only return occasionally (hopefully with more good news).

Take care.

 

[Hudson]

my only worry right now is that my (treted) ear is still aching, when I'm for example yawning or mowing my inner ear. Also when I was in bed the last day, i could hear my pulse on my eardrum! I've never had that before. I'm calling my study-doctor today to ask her. On the other hand: I could hear my pulse and not my T !!

I have heard my pulse in my ear when laying down my whole life, even before t. That is normal. I would assume you will feel some pain or discomfort until the puncture hole heals up.

 

[locoyeti]

urtica when was the last time you had your injection? has it not healed by now?

 

[Mpt]

hi urtica... how hard is it to hear t in the treated ear now... do you notice it in a quiet room or do you literally have to put your fingers in your ears to hear it?

 

[attheedgeofscience]

Indeed the numbers for AM101 look really good.

And maybe you know something about this;

Could it be that they use really small doses? I saw a report that said "Dose 1.5x" gave no results, but "Dose 4x" gave good results.

Could it be that "Dose 15x" is safe, and will completely cure people? That would be cool.

I will discuss this with the ENT specialist performing the procedure. But, since I will be signing papers releasing the doctor from responsibility, I believe I can pretty much have it the way I want it...

In any event, I will let you know what dose I end up being treated with.

I know nothing about Ketamine except that it is a drug sometimes used in emergency medicine (because it doesn't suppress breathing) and in animals.

 

[attheedgeofscience]

@attheedgeofscience Would you be interested in opening a new topic about this? I'm afraid this information will get lost between the AM-101 messages in this thread.

You will need to discuss this with the administrators of this site (if they deem it relevant enough). In any event, I will make sure you, Robb, Johno, and Erlend get the necessary information (one way or another).

 

[David S]

Dose anybody kow if AM101 seams to work best for high ptich or low pitch T. Dose it matter?

 

[Robb]

You will need to discuss this with the administrators of this site (if they deem it relevant enough). In any event, I will make sure you, Robb, Johno, and Erlend get the necessary information (one way or another).

Thanks attheedgeofscience

 

[JohnDoe]

@urtica: Do you still hear your Tinnitus? Have you noticed any side effects?

 

[urtica]

my t is on alltime low the last days! i really just notice it while I'm stressed, whith earplugs or drunk. And
it has gone from a tone to a low hissing sound. The sideffects of the injection now completely wore off. last friday I had some custom fit earplugs molded and the guy said I still had a small bloodcrust on my eardrum. by now it has probably fallen off. right now I'm pretty happy with my ears! But I had a low T before the trial as well and it has improved on both ears. The right one, which was worse before and got treated, is now slighty better than the untreated left one.

 

[Mpt]

would you notice it in a silent room now if you weren't stressed, because if not, I would say you are pretty much healed, at least in my oppinion ...do you think the fact that it has improved in both ears could be due to time/habituation and not the drug... since the untreated ear is improving as well

 

[Grace]

Dose anybody kow if AM101 seams to work best for high ptich or low pitch T. Dose it matter?

Shouldnt matter the pitch high or low... Just has to be from noise exposure or something else on there but mayb it will work on all T who knows...

 

[ResonanceCEO]

The drug itself should work on both high and low pitch, however the part of your cochlea that produces low pitch sound (and tinnitus) is very hard to reach anatomically. The low pitch basically at the far end of a long tube, and a gel is gone before the drug can diffuse that far. In order to reach the distal end of the cochlea, you need sustained delivery over days to weeks.

 

[Erlend]

The drug itself should work on both high and low pitch, however the part of your cochlea that produces low pitch sound (and tinnitus) is very hard to reach anatomically. The low pitch basically at the far end of a long tube, and a gel is gone before the drug can diffuse that far. In order to reach the distal end of the cochlea, you need sustained delivery over days to weeks.

Can your tinnitus ears mimic sounds from your surroundings? Electrical leak sound from the power plug for my internet router makes a spesific sound, and I now have a tinnitus sound that I can describe as a spinning rusty metal wheel. It is most prominent in the right ear, but I can also hear it in the left, but it's not the same.

This sound has either become louder over the last few months, or I can hear it better because "the rest" of my tinnitus is getting lower.

I just think it's weird that I have a tinnitus sound that seems completely seperated from the "other", "main"-tinnitus..

 

[ResonanceCEO]

I can see how that might happen, however I'm not sure that I have the knowledge/ability to figure that out. When was the last time you saw an otologist or had your hearing checked?

 

[Mpt]

Hi Chris,

I was wondering what your oppinion of AM-101 is, its efficacy, etc. Any thoughts at all are appreciated.

Thanks,

 

[ResonanceCEO]

I think its the first step in a long line of drugs for T that will be coming out in the next few years. Please keep in mind that it is only good for acute tinnitus (i.e.- the first couple of days, maybe a week). If you have tinnitus that's been around for a while, follow Autifony - in phase I clinical trials.